Quality & Safety
Artivion’s Commitment to Excellence in Patient Safety
Artivion’s comprehensive Quality System is designed to achieve high-quality standards through strict levels of quality control. Artivion’s achievement of quality is indicative of the importance placed on meeting patients’ and customers’ needs and is exemplified by the high-quality products being offered.
Collectively, our Artivion team owns Quality. Our goal is that each team member uniquely applies personal accountability in all areas of our business to those we are entrusted to serve. We accomplish this goal by complying with applicable regulatory and customer requirements and by, maintaining the effectiveness of the Quality Management System, and through the establishment and review of quality objectives.
Artivion’s Quality Management System is in accordance with 21 CFR Part 820 – Medical Devices, Quality System Regulation, 21 CFR Part 1270 – Human Tissue Intended for Transplantation, and 21 CFR Part 1271 – Human Cells Tissues and Cellular and Tissue-Based Products. CryoLife’s Quality Management System also incorporates the requirements of applicable ISO Standards, as well as European Medical Device Directives, Australian Medical Device Requirements, Health Canada Medical Device Regulations, and Health Canada Tissue Regulations.
Artivion emphasizes a total quality assurance approach to all aspects of the business. Awareness of Quality Systems and procedures is maintained through employee training and is practiced company-wide.
The Artivion Quality Management System provides the organizational structure to ensure that products are processed, manufactured, controlled, and distributed according to the appropriate regulatory requirements and corporate policies/procedures. Continuous quality improvement is the basis for the Quality Management System. The periodic reviews of the system identify the strategic plans required to develop, implement, and modify the Quality Management System and identify the processes, controls, equipment, fixtures, resources, and skills necessary to meet ongoing quality requirements.
Artivion, Inc. is a U.S. FDA-registered medical device establishment (Registration # 1063481) and human cells, tissues, and cellular and tissue-based product establishment (#3001451326). In addition, Artivion is licensed or registered by the States of Georgia, New York, Florida, California, Maryland, Pennsylvania, Illinois, and Delaware. Artivion is certified to the international quality standards (ISO 13485:2016) for the design, manufacture, and distribution of tissues and medical devices. Artivion’s Microbiology Laboratory is a State of Georgia-licensed Clinical Laboratory, is a federally licensed CLIA Laboratory, and participates annually in the College of American Pathologists (CAP) Performance Surveys.
Certificates & Licenses
- American Association of Tissue Banks (AATB) Certificate
- Delaware Tissue Bank Registration Confirmation
- MDSAP ISO 13485:2016 Certificate
- State of California Tissue Bank License
- State of Florida Tissue Bank License
- State of Georgia Clinical Laboratory License
- State of Illinois Letter of Registration
- State of Louisiana Distributor of Legend Drugs or Legend Devices License
- State of Maryland Medical Laboratory Permit
- State of Maryland Tissue Bank Permit
- State of New York Tissue Bank License
- State of Oregon Letter of Registration 2017-2020
- State of Pennsylvania Drug & Device Registration
- US FDA Annual Registration of Device Establishment
- US FDA Annual Registration of Tissue Establishment